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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025555
Receipt No. R000029244
Scientific Title HMG-CoA Reductase Inhibitor for postmenopausal patients used as Arterial stiffness (ASI) index ; A Phase II randomized controlled study
Date of disclosure of the study information 2017/01/06
Last modified on 2017/01/06

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Basic information
Public title HMG-CoA Reductase Inhibitor for postmenopausal patients used as Arterial stiffness (ASI) index ; A Phase II randomized controlled study
Acronym HMG-CoA Reductase Inhibitor for postmenopausal patients used as ASI index
Scientific Title HMG-CoA Reductase Inhibitor for postmenopausal patients used as Arterial stiffness (ASI) index ; A Phase II randomized controlled study
Scientific Title:Acronym HMG-CoA Reductase Inhibitor for postmenopausal patients used as ASI index
Region
Japan

Condition
Condition Postmenopausal women (70> age >40years) with hypecholesterolemia (LDL> 140mg/dl)
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 HMG-CoA Reductase Inhibitor for postmenopausal patients with hypecholesterolemia with randomized control phase II study examine whether exercise therapy and dietary therapy and HMG-CoA Reductase Inhibitor are superior to therapy and dietary therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase II

Assessment
Primary outcomes the rate of change of ASI 1 year later after treatment
Key secondary outcomes the rate of change of TCHO, LDL and HDL value 1 year later after treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 kinesitherapy and deiotherapy are based on third Report of the National Cholesterol Education Program (NCEP) for 1 year.
Interventions/Control_2 Pravastatin (10mg/day) is administered for 1 year.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
70 years-old >=
Gender Female
Key inclusion criteria Postmenopausal women with hypercholesterolemia (LDL>=140mg/dl)
Key exclusion criteria 1.familial hypercholesterolemia
2.allergy to Pravastatin
3.pregnant woman
4.hypertension
5.angina pectoris or myocardial infarction
6.stroke
7.Atrial fibrillation
8.Rheumatism
9.hepatitis or Cirrhosis of the liver
10.cancer patient
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuji Kawaguchi
Organization Nara Medical University
Division name Obstetrics and Gynecology
Zip code
Address 840 shijocho, Kashihara, Nara, Japan
TEL 0744-22-3051
Email kawaryu@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryuji Kawaguchi
Organization Nara Medical University
Division name Obstetrics and Gynecology
Zip code
Address 840 shijocho, Kashihara, Nara, Japan
TEL 0744-22-3051
Homepage URL
Email kawaryu@naramed-u.ac.jp

Sponsor
Institute Obstetrics and Gynecology, Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 奈良県立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 28 Day
Last follow-up date
2016 Year 05 Month 31 Day
Date of closure to data entry
2016 Year 05 Month 31 Day
Date trial data considered complete
2016 Year 05 Month 31 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 06 Day
Last modified on
2017 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029244

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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